CIP Protocol Review & Approval Process

Question 1

What is the first step in the IRB protocol review process?

Accepted Answer

Submitting the protocol

Answer

The first essential step in the IRB protocol review process is for the researcher to formally submit their complete research protocol to the IRB. This submission includes all necessary documents, such as the detailed research plan, informed consent forms, and recruitment materials. The IRB cannot begin its ethical and regulatory review until all required documentation has been received.

Question 2

What type of IRB review is required for minimal risk research?

Accepted Answer

Expedited review

Answer

Expedited review is a streamlined IRB review process for research that involves no more than minimal risk to participants and falls into specific regulatory categories. This allows a single IRB member or a small subcommittee to review the protocol, rather than the full board. It ensures ethical oversight while expediting approval for low-risk studies.

Question 3

What does a full board review entail?

Accepted Answer

Review by entire committee

Answer

A full board review is mandated for research protocols that involve more than minimal risk to participants or do not qualify for expedited or exempt review. During this process, the entire IRB committee convenes to thoroughly discuss and vote on the protocol. This comprehensive review ensures that complex ethical issues and higher risks are rigorously scrutinized by multiple experts.

Question 4

What happens if the IRB requests modifications to a protocol?

Accepted Answer

Make required changes

Answer

If the IRB requests modifications to a protocol, it means they have identified areas that need adjustment to ensure participant safety, ethical conduct, or regulatory compliance. Researchers are obligated to address these concerns by making the required changes and resubmitting the revised protocol. The study cannot proceed until the IRB is satisfied and grants full approval.

Question 5

What documentation is needed for protocol approval?

Accepted Answer

Protocol, consent forms, supporting documents

Answer

For IRB protocol approval, a comprehensive set of documentation is required to allow the board to fully assess the study. This typically includes the detailed research protocol outlining the study design, methodology, and procedures, along with informed consent forms, recruitment materials, and any other relevant supporting documents. These provide the IRB with a complete picture of the proposed research.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Protocol Review & Approval Process